Rocking Chairs as Post-operative Treatment for Older Adults After Hip Surgery

Официальное название

Feasibility and Acceptability of the Impact of a Rocking Chair Intervention on Recovery Compared to Standard Care of Stationary Chair on Older Adults After Elective Orthopedic Hip Surgery: A Randomized Controlled Trial

Обзор

Feasibility and acceptability randomized controlled trial exploring the use of a rocking chair after a total hip arthroplasty in adults who are aged 65 or older. Primary aims include its feasibility and acceptability; exploratory aims include the impact of rocking on pain, gastrointestinal effects, anxiety, ambulation, and additional healthcare visits.

Вмешательства

• Поведенческое Active rocking in a rocking chair
  Participants will actively rock 3 times per day for 30 minutes in a rocking chair
• Поведенческое Sitting upright in a stationary chair
  Participants will sit upright in a stationary chair 3 times per day for 30 minutes

Первичные конечные точки

• Number of participants that enroll and complete study assessed by Feasibility Participant Questionnaire (developed by investigators) [Срок оценки: From enrollment to 31-day follow-up]
• Total participants reporting acceptability of rocking or sitting as measured by Acceptability for Participants Questionnaire [Срок оценки: From enrollment to 31-day follow-up]

Вторичные конечные точки (6)

• Total participants indicating Nausea using the PROMIS Scale v1.0 GI Nausea and Vomiting 4A [Срок оценки: From surgery (Day 1 of the study) to 31-day follow-up]
• Total participants reporting Gas/bloating via PROMIS v1.1 GI Gas and Bloating 13A [Срок оценки: From surgery (Day 1 of the study) to end of 31-day follow-up]
• Total participants reporting Daily pain assessed by PROMIS v2.0 pain intensity 3A [Срок оценки: From surgery (Day 1 of the study) to end of 31-day follow-up]
• Total amount of participants' Daily Ambulation as measured using steps via activPAL4pro accelerometer [Срок оценки: After surgery (Day 1 of the study) and up to 7 days post-surgery]
• Total amount of participants' Daily anxiety measured using the Anxiety subscale of the Neuro-QoL Hospital Anxiety and Depression Scale [Срок оценки: From enrollment through 31-day follow-up]
• Participants' self-reported Additional healthcare visits since their surgery, as assessed via phone call at 31-days post-surgery [Срок оценки: From surgery (Day 1 of the study) until 31-day follow-up]

Критерии участия

Критерии включения

• scheduled to undergo an elective primary total hip arthroplasty
• Weigh less than 163kg (limit of rocking chair)
• Able to consent
• Able to rock with at least one leg

Критерии исключения

• Unable to sit in a chair for at least 30 minutes at a time
• Hospitalized more than 24 hours after surgery
• Cannot read and understand the English language
• Planned disposition to rehabilitation facility or skilled nursing facility
• Known vestibular dysfunction (such as Menieres, traumatic brain injury, vertigo)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07544550 · 457957

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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